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NIOPEG is a brand name for Pegfilgrastim, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indication has been granted on the basis of similarity between Niopeg and the reference biologic drug Pegfilgrastim (pegfilgrastim). Niopeg (pegfilgrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Niopeg (pegfilgrastim) should be administered no sooner than 24 hours after the administration of cytotoxic chemotherapy (see 7 WARNINGS AND PRECAUTIONS). Renal impairment, including end-stage renal disease, appears to have no effect on the pharmacokinetics of pegfilgrastim and no dosage adjustment is required.
2 Recommended Dose and Dosage Adjustment The recommended dosage of Niopeg is a single subcutaneous injection of 6 mg, administered once per cycle of chemotherapy. Niopeg should be administered no sooner than 24 hours after the Serious Warnings and Precautions • Splenic rupture, including fatal cases, has been reported following the administration of pegfilgrastim and its parent compound, filgrastim (see 7 WARNINGS AND PRECAUTIONS: General).
• Severe sickle cell crisis have been associated with the use of pegfilgrastim in patients with sickle cell trait or sickle cell disease. Severe sickle cell crises, in some cases resulting in death, have also been associated with filgrastim, the parent compound of pegfilgrastim (see 7 WARNINGS AND PRECAUTIONS, Hematologic).
Niopeg (pegfilgrastim) Product Monograph Page 5 of 36 administration of cytotoxic chemotherapy (see 7 WARNINGS AND PRECAUTIONS). 3 Reconstitution Not applicable. Product does not need to be reconstituted. 4 Administration Niopeg is intended for subcutaneous injection only and should not be given by any other route of administration.
Niopeg should not be mixed with any diluents. Niopeg should not be vigorously shaken. Niopeg is supplied in prefilled syringes with a BD UltraSafe Plus™ Passive Needle Guard. Following administration of Niopeg from the prefilled syringe, the Needle Guard is automatically activated to cover the needle after the injection is given.
The Needle Guard will help prevent stick injuries to anyone who handles the prefilled syringe. The prefilled syringe should be disposed of by placing the entire prefilled syringe with activated Needle Guard into an approved puncture-proof container.
5 Missed Dose If a scheduled dose is missed, Niopeg should not be administered less than 14 days before subsequent administration of cytotoxic chemotherapy.
). Because of the potential for patients to receive full doses of chemotherapy on the prescribed schedule‚ patients may be at greater risk of thrombocytopenia‚ anemia‚ and non- hematologic consequences of increased chemotherapy doses (please refer to the prescribing information for specific chemotherapy agents).
Regular monitoring of hematocrit value and platelet count is recommended. Furthermore‚ care should be exercised in the administration of Niopeg in conjunction with drugs known to lower platelet count. Thrombocytopenia Thrombocytopenia, including serious events, has been reported in patients receiving pegfilgrastim.
Platelet count should be monitored regularly as clinically indicated. Immune Hypersensitivity/Allergic Reactions Hypersensitivity including serious allergic reactions and anaphylactic reactions, skin rash, urticaria and erythema/flushing occurring on initial or subsequent treatment have been reported both with pegfilgrastim and filgrastim.
In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship. In rare cases, allergic reactions, including anaphylactic reactions, recurred within days after initial anti-allergic treatment was discontinued.
If a serious allergic reaction or an anaphylactic reaction occurs, appropriate therapy should be administered and further use of Niopeg should be discontinued. Antibodies to filgrastim or pegfilgrastim have been reported, although no neutralizing antibodies have been reported (see 8 ADVERSE REACTIONS; Immunogenicity).
Do not administer filgrastim to patients with a history of hypersensitivity to filgrastim or pegfilgrastim. Cutaneous Vasculitis Uncommon (≥1/1,000 to <1/100) events of cutaneous vasculitis have been reported in patients treated with pegfilgrastim sterile solution for injection.
The mechanism of vasculitis in patients receiving pegfilgrastim is unknown. Monitoring and Laboratory Tests To assess a patient's hematologic status and ability to tolerate myelosuppressive chemotherapy, a complete blood count (CBC) and platelet count should be obtained before chemotherapy is administered.
, Carcinogenesis and Mutagenesis 7 WARNINGS AND PRECAUTIONS, Hematologic TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .......................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................................ 4 1 INDICATIONS ....................................................................................................................................
1 Pediatrics (<18 years of age): ......................................................................................................... 4 2 CONTRAINDICATIONS .....................................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .......................................................................... 4 4 DOSAGE AND ADMINISTRATION ...................................................................................................
1 Dosing Considerations ................................................................................................................... 2 Recommended Dose and Dosage Adjustment ...............................................................................
3 Reconstitution ................................................................................................................................. 4 Administration .................................................................................................................................
5 Missed Dose ................................................................................................................................... 5 5 OVERDOSAGE ..................................................................................................................................
Niopeg (pegfilgrastim) is contraindicated in patients with known hypersensitivity to E. coli-derived products‚ pegfilgrastim‚ filgrastim, or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container.
For a complete listing of the components, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Pegfilgrastim in Canada.
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Pegfilgrastim produced ANC (absolute neutrophil count) profiles similar to daily filgrastim, including earlier ANC nadir, shorter duration of severe neutropenia, and accelerated ANC recovery, compared with ANC profiles observed without growth factor support.
Regular monitoring of hematocrit value, white blood cell count and platelet count, as clinically indicated, is recommended. Niopeg (pegfilgrastim) Product Monograph Page 9 of 36 Renal Glomerulonephritis Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim.
Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim. Urinalysis monitoring is recommended. Respiratory Acute Respiratory Distress Syndrome Acute respiratory distress syndrome (ARDS) has been reported following administration of pegfilgrastim and is postulated to be secondary to an influx of neutrophils to sites of inflammation in the lungs.
Neutropenic patients receiving Niopeg who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. In the event that ARDS occurs, Niopeg should be discontinued and/or withheld until resolution of ARDS, and patients should receive appropriate medical management for this condition.
Sexual Function/Reproduction No studies evaluating sexual function or reproduction in humans were conducted with Niopeg. 1 Pregnant Women There were no pregnant women exposed to pegfilgrastim in clinical trials. Niopeg should be used during pregnancy only if the potential benefit outweighs the risk to the fetus (see 1 6 NON-CLINICAL TOXICOLOGY).
2 Breast-feeding It is not known whether pegfilgrastim is excreted in human milk. Because many drugs are excreted in human milk‚ Niopeg is not recommended for women who are breast-feeding. Niopeg should only be administered to a nursing woman if the potential benefit outweighs the risk.
3 Pediatrics Pediatrics (<18 years of age): The safety and effectiveness of Niopeg in pediatric patients have not been established. 4 Geriatrics Geriatrics (>65 years of age): Of the total number of patients with cancer who received pegfilgrastim in clinical studies (n = 930), 139 patients (15%) were 65 years or older and 18 patients (2%) were 75 years or older.
No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients; however, due to the small number of elderly subjects, small but clinically relevant differences cannot be excluded.
8 ADVERSE REACTIONS Niopeg (pegfilgrastim) Product Monograph Page 10 of 36 The adverse drug reaction profiles reported in clinical studies that compared Niopeg (pegfilgrastim) to the reference biologic drug were comparable. The description of adverse reactions in this section is based on clinical experience with the reference biologic drug.
1 Adverse Reaction Overview The most frequently reported study drug-related adverse event was bone pain, for which the incidence in patients treated with pegfilgrastim was similar to that in patients treated with filgrastim. Bone pain was generally reported as mild-to-moderate, could be controlled in most patients with non-narcotic analgesia.
See 7 WARNINGS AND PRECAUTIONS regarding Splenic Rupture, ARDS, H ypersensitivity/Allergic Reactions, and Sickle Cell Crises. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying and for […]
5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING........................................... 5 7 WARNINGS AND PRECAUTIONS .................................................................................................... 1 Special Populations ........................................................................................................................
1 Pregnant Women............................................................................................................................ 2 Breast-feeding ................................................................................................................................
3 Pediatrics ........................................................................................................................................ 4 Geriatrics ........................................................................................................................................
9 8 ADVERSE REACTIONS .................................................................................................................... 1 Adverse Reaction Overview ..........................................................................................................
2 Clinical Trial Adverse Reactions ................................................................................................... 3 Less Common Clinical Trial Adverse Reactions ...........................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .. 5 Post-Market Adverse Reactions ................................................................................................... 13 9 DRUG INTERACTIONS ...................................................................................................................
1 Serious Drug Interactions ............................................................................................................. 2 Drug Interactions Overview ..........................................................................................................
3 Drug-Behavioural Interactions ...................................................................................................... 4 Drug-Drug Interactions .................................................................................................................
5 Drug-Food Interactions ................................................................................................................. 6 Drug-Herb Interactions .................................................................................................................
7 Drug-Laboratory Test Interactions ................................................................................................ 14 10 CLINICAL PHARMACOLOGY ........................................................................................................
1 Mechanism of Action .................................................................................................................... 2 Pharmacodynamics ......................................................................................................................
3 Pharmacokinetics ......................................................................................................................... 15 11 STORAGE, STABILITY AND DISPOSAL .......................................................................................
16 12 SPECIAL HANDLING INSTRUCTIONS .......................................................................................... 17 PART II: SCIENTIFIC INFORMATION ....................................................................................................
18 13 PHARMACEUTICAL INFORMATION […]